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FDA 510(k)

SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE

K-Number: K080439 · 2008-05-16

ApplicantMallinckrodt Developpement France
Decision Date2008-05-16
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Developpement France. It received FDA 510(k) clearance on 2008-05-16 under 510(k) number K080439. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE?

SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE is a medical device that received FDA 510(k) clearance on 2008-05-16. The listed applicant is Mallinckrodt Developpement France. The 510(k) number is K080439.

When did SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE receive FDA 510(k) clearance?

SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE received FDA 510(k) clearance on 2008-05-16, under 510(k) number K080439.

Who is the listed applicant for SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE?

The FDA 510(k) record lists Mallinckrodt Developpement France as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE?

The FDA product code for SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE is BZD.

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Other records listing Mallinckrodt Developpement France as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082237PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO STK071575SANDMAN INTROK063501KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-USK042184GOODKNIGHT H20, MODEL M-114600-00K041819GOODKNIGHT 425, MODELM-114500-00K001845MALLINCKRODT, GOODKNIGHT 418S

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Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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